Quetiapine Augmentation for Treatment-resistant PTSD

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: AstraZeneca
• Treatments: Paroxetine; Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Veteran age 18 to 75.

• Competent to give informed consent.

• Meeting DSM-IV criteria for PTSD.

• Minimal CAPS score of 50 at baseline.

• If female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method.

• Patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine [5 weeks])

• monoamine oxidase inhibitors (MAOIs [4 weeks])

• depot neuroleptics [4 weeks])

• or any investigational drug within 30 days prior to study enrollment.

• To be eligible for Phase II

• patients must be refractory to paroxetine in Phase I, as defined by less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8

• must have PTSD symptoms at least moderate severity on CGI-S

• and must have been compliant with study medicine in Phase I, as defined by taking at least 80% of prescribed doses.

Exclusion Criteria:

• History of sensitivity to paroxetine or quetiapine.

• Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily).

• Women who are

• breast-feeding

• pregnant

• expect to become pregnant during the course of the study

• or are sexually active and are not using a medically acceptable method of birth control.

• Presence of clinically significant hepatic

• cardiovascular

• or other medical conditions that may prevent safe administration of paroxetine or quetiapine

• or any other clinically significant unstable medical conditions.